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EP1399111B1 - Injizierbare sterile zusammensetzung als schönheits- und/oder korrekturzweck - Google Patents

Injizierbare sterile zusammensetzung als schönheits- und/oder korrekturzweck Download PDF

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Publication number
EP1399111B1
EP1399111B1 EP02748952A EP02748952A EP1399111B1 EP 1399111 B1 EP1399111 B1 EP 1399111B1 EP 02748952 A EP02748952 A EP 02748952A EP 02748952 A EP02748952 A EP 02748952A EP 1399111 B1 EP1399111 B1 EP 1399111B1
Authority
EP
European Patent Office
Prior art keywords
composition
composition according
dye
skin
vector
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP02748952A
Other languages
English (en)
French (fr)
Other versions
EP1399111A1 (de
Inventor
Philippe Bellity
S.A. Ioltech
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bellity Philippe
Ioltech SA
Original Assignee
Ioltech SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ioltech SA filed Critical Ioltech SA
Publication of EP1399111A1 publication Critical patent/EP1399111A1/de
Application granted granted Critical
Publication of EP1399111B1 publication Critical patent/EP1399111B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/52Hydrogels or hydrocolloids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/06Flowable or injectable implant compositions

Definitions

  • the invention relates to a novel injectable sterile composition for esthetic and / or restorative purposes and to the use of a mixing apparatus for preparing said composition. It is also intended for use in a method of aesthetic and / or restorative treatment.
  • the skin often has many imperfections such as spots, depigmentations, vein marks visible through the skin, deep circles, scars ... These differences in color, these pigmentation abnormalities are often considered unsightly.
  • the daily practice of cosmetic and reconstructive surgery has allowed the inventor to see a growing demand for this type of restorative intervention. Until today, this demand was not satisfied, for lack of appropriate means to compensate for problems of color differences of the skin.
  • the object of the invention is therefore to provide a sterile injectable composition capable of restoring the desired aesthetic to the skin. It also proposes the use of a mixing apparatus making it possible to manufacture said composition.
  • the sterile injectable composition for aesthetic and / or restorative purposes is characterized in that it comprises, in an effective amount, at least one colorant of suitable color and a biocompatible vector making it possible to control the diffusion of said dye, during Subcutaneous, subdermal injection and / or intra-dermal of said composition, precisely on the area to be treated.
  • a biocompatible vector is any vector that can be injected, without danger to health, into a part of the human body, and which is tolerated by it.
  • the vector of such a composition comprises at least one gel, preferably bioresorbable, allowing the dye not to migrate.
  • This gel is preferably chosen from the group comprising a hyaluronic acid and / or a collagen.
  • An example of a suitable nonabsorbable vector is given by silicone.
  • Such gels, resorbable or not, are introduced into the composition in sufficient quantity to give the composition a sufficient viscosity to leave in place the internal makeup, once the injection is made. Indeed, the more the composition is viscous, the more precise its location will be. On the other hand, too much viscosity can induce deformation of the skin.
  • the dye of this composition is chosen according to the complexion of the skin to be treated. Its hue is identical to that of the skin. It is preferable to play on the dilution of the dye in the composition to define the intensity of the coloring. To be usable for injection purposes, the dye must have health safety guarantees.
  • the proportion of dye to be introduced into the composition according to the invention varies according to the degree of transparency of the skin of the subject to be treated. In general, the clearer the skin, the greater the dilution.
  • composition of the invention is sterile because it is intended to be injected subcutaneously, subdermally and / or intradermally to form a screen under the dermis, under the epidermis and / or in the dermis.
  • the invention also proposes the use of a mixing apparatus capable of preparing the dye of the composition according to the invention after analysis of the coloration of the skin of the subject to be treated.
  • the apparatus used comprises a colorimeter to reconstitute a specific shade, from a range of dyes, by mixing them, in proportions calculated by the mixing apparatus.
  • the apparatus used may, on the other hand, advantageously combine a colorimeter and a viscometer so as to prepare the composition according to the invention extemporaneously.
  • the choice of the vector and the final viscosity of the composition is defined by the practitioner according to the parameters mentioned above.
  • the apparatus can then, based on these data, make a composition having the desired hue and viscosity.
  • the use of the apparatus according to the invention can be sterile so that the prepared composition can be used immediately.
  • the invention also aims at providing a method of aesthetic treatment by internal makeup of the skin, characterized in that a subcutaneous, subdermal and / or intradermal injection of the composition according to the invention is carried out in order to create an opaque screen localized while leaving intact the transparency of the upper layers of the epidermis.
  • the choice of the type of injection depends on the fineness of the skin to be treated.
  • an intra-dermal injection is used for the makeup of a scar, whereas the makeup of a ring is performed by a subdermal injection.
  • the injection is therefore performed at a given depth, dependent on the area to be treated, the thickness and the transparency of the skin.
  • the quantity of product to be injected as well as the number of injections depend on the extent of the area to be treated and its location on the body.
  • the advantage of such a method is to be able to correct imperfections of the skin in transparency.
  • the injections are localized in depth, by subcutaneous, subdermal and / or intradermal lapping of the area to be treated with the aid of the composition, the transparent appearance of the upper layers of the epidermis is preserved. This method makes it possible to obtain a very natural result.
  • such a method can illuminate or darken a specific skin area. It also makes it possible to mask the darkness of dark circles by subdermal dyeing, to recolor depigmentation spots or to mask veins.
  • veins near the surface of the skin to show a blue mark on it.
  • the injection of the composition between the surface of the skin and the vein forms a kind of colored and opaque screen making disappear such marks.
  • This method finally makes it possible to make up a scar having an unsightly appearance due to a problem of coloring.
  • FIG. 1 illustrates the makeup of an apparent vein with the invention.
  • Example 1 deep opacification of the skin to remove a vein mark in a fair skinned subject.
  • the injection is therefore performed subdermally.
  • the amount injected is about 1 cm 3 .
  • the injection is made in a single puncture, the needle being movable to distribute the product (how to operate identical to that used to repair wrinkles).
  • Figures 1A and 1C show the location of the vein on the subject's arm, before the injection (1A) and three months after the injection (1C). We can see the disappearance of the mark of the vein. It should be noted that the hue of the composition used blends well into the skin tone of the subject.
  • Figure 1B illustrates the injection of the composition.
  • Example 2 Use of the mixer device.
  • the mixing apparatus comprises a colorimeter. At first, it is calibrated using a range of skin colors. Such a range is commercially available.
  • the dye is then mixed with the vector and a suitable solvent.
  • the viscometer controls the respect of the data.
  • the composition is delivered in an ampoule after sterilization.
  • a simplified version of the mixing apparatus has a choice of hyaluronic acids at predefined viscosities. It is then sufficient to choose the type of hyaluronic acid to mix in the composition.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (11)

  1. Injizierbare sterile Zusammensetzung zu ästhetischen und/oder Ausbesserungszwecken, dadurch gekennzeichnet, dass sie in wirksamer Menge mindestens einen opaken Farbstoff mit einem Farbton, welcher mit demjenigen der zu behandelnden Haut identisch ist, und einen biokompatiblen Vektor aufweist, der das Kontrollieren der Diffusion des Farbstoffs bei der Injektion durch subkutanes, subdermales und/oder intradermales Auftragen der Zusammensetzung genau auf die zu behandelnde Zone ermöglicht.
  2. Zusammensetzung nach Anspruch 1, dadurch gekennzeichnet, dass der Vektor mindestens ein Gel, vorzugsweise ein biologisch resorbierbares Gel, aufweist, welches das Wandern des Farbstoffs verhindert.
  3. Zusammensetzung nach Anspruch 2, dadurch gekennzeichnet, dass das Gel aus der Gruppe gewählt ist, die aus einer Hyaluronsäure, einem Kollagen und/oder einem Silikon besteht.
  4. Zusammensetzung nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass der Vektor in ausreichender Menge in die Zusammensetzung eingebracht ist, um dieser eine Viskosität zu vermitteln, welche es dieser ermöglicht, an ihrer Position zu verbleiben, ohne die behandelte Zone zu verformen.
  5. Verwendung eines Kolorimeters/Mischers zur sofortigen Herstellung des Farbstoffs der Zusammensetzung nach einem der Ansprüche 1 bis 4, ausgehend von einer Farbstoffpalette, dadurch gekennzeichnet, dass das Kolorimeter mit einem Viskosimeter kombiniert ist, wodurch die unmittelbare Herstellung der Mischung aus Vektor und Farbstoff der Zusammensetzung nach einem der Ansprüche 1 bis 4 möglich ist.
  6. Verwendung nach Anspruch 5, dadurch gekennzeichnet, dass sie die sterile Herstellung der Zusammensetzung der Ansprüche 1 bis 4 ermöglicht.
  7. Verfahren zur ästhetischen und/oder Ausbesserungsbehandlung durch inneres Kaschieren, dadurch gekennzeichnet, dass die Zusammensetzung nach einem der Ansprüche 1 bis 4 subkutan, subdermal und/oder intradermal injiziert wird, um eine lokale opake Abdeckung zu erzeugen, wobei gleichzeitig die Transparenz der oberen Schichten der Epidermis unbeschadet bleibt.
  8. Verfahren nach Anspruch 7 zum Korrigieren von Transparenzzonen der Haut.
  9. Verfahren nach Anspruch 7, das ein Aufhellen oder Abdunkeln einer bestimmten Hautzone ermöglicht.
  10. Verfahren nach Anspruch 7 zum Abdecken von Augenringen, Venen und/oder depigmentierter Flecken.
  11. Verfahren nach Anspruch 7 zum Kaschieren einer Narbe.
EP02748952A 2001-06-18 2002-06-13 Injizierbare sterile zusammensetzung als schönheits- und/oder korrekturzweck Expired - Lifetime EP1399111B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0107981A FR2825924B1 (fr) 2001-06-18 2001-06-18 Composition sterile injectable a visee esthetique et/ou reparatrice
FR0107981 2001-06-18
PCT/FR2002/002033 WO2002102328A1 (fr) 2001-06-18 2002-06-13 Composition sterile injectable a visee esthetique et/ou reparatrice

Publications (2)

Publication Number Publication Date
EP1399111A1 EP1399111A1 (de) 2004-03-24
EP1399111B1 true EP1399111B1 (de) 2007-02-14

Family

ID=8864454

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02748952A Expired - Lifetime EP1399111B1 (de) 2001-06-18 2002-06-13 Injizierbare sterile zusammensetzung als schönheits- und/oder korrekturzweck

Country Status (8)

Country Link
EP (1) EP1399111B1 (de)
AT (1) ATE353624T1 (de)
DE (1) DE60218157T2 (de)
DK (1) DK1399111T3 (de)
ES (1) ES2281530T3 (de)
FR (1) FR2825924B1 (de)
PT (1) PT1399111E (de)
WO (1) WO2002102328A1 (de)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011119729A1 (de) 2011-11-30 2013-06-06 S & V Technologies Ag Polymerisierbare Farbstoffe und deren Zusammensetzungen für opthalmologische Anwendungen
US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2005117995A1 (ja) * 2004-06-03 2008-04-03 丈二 北山 ヒアルロン酸のセンチネルリンパ節同定への応用
CN105769603A (zh) * 2016-03-02 2016-07-20 陈思敏 一种微注粉底及其制备方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2774695B2 (ja) * 1991-03-29 1998-07-09 コラーゲン コーポレイション 顔のしわを処置する装置および方法
WO2000051553A1 (en) * 1999-03-01 2000-09-08 The General Hospital Corporation An anti-reflective cosmetic composition for reducing the visibility of wrinkles

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof
DE102011119729A1 (de) 2011-11-30 2013-06-06 S & V Technologies Ag Polymerisierbare Farbstoffe und deren Zusammensetzungen für opthalmologische Anwendungen
WO2013079055A1 (de) 2011-11-30 2013-06-06 S&V Technologies Ag Polymerisierbare farbstoffe und deren zusammensetzungen für opthalmologische anwendungen

Also Published As

Publication number Publication date
EP1399111A1 (de) 2004-03-24
ES2281530T3 (es) 2007-10-01
FR2825924B1 (fr) 2007-02-09
DE60218157D1 (de) 2007-03-29
WO2002102328A1 (fr) 2002-12-27
PT1399111E (pt) 2007-04-30
FR2825924A1 (fr) 2002-12-20
DE60218157T2 (de) 2007-10-31
ATE353624T1 (de) 2007-03-15
DK1399111T3 (da) 2007-06-11

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